The increasing prominence of blood-borne infectious disease, including the HIV virus and hepatitis, has lead to increased concern by surgeons of the risks of contracting such disease by inadvertent cuts occurring during the routine handling of medical instruments, particularly scalpels.
In response to these concerns, scalpels having retractable blades or extensible guards have been developed, such as are described in U.S. Pat. Nos. 5,344,424, 5,330,493, 5,330,492, 5,292,329, 5,275,606, 5,258,001, 5,211,652 and 5,201,748. A disadvantage common to all of these and other previously known safety scalpels is that these designs have radically different shapes, handling and ergonomic characteristics from standard scalpels having non-retractable blades. Consequently, there is significant resistance to adopting these scalpel designs, notwithstanding their safety features, because such scalpels require significant changes from conventional surgical handling techniques.
For example, it is common for the scalpel blade to be changed during the course of an operation. This procedure is typically performed by a nurse, who removes the old blade, and engages the new one, using a forceps and a simple twisting motion. This standard procedure is taught in nursing schools as an important feature of handling surgical scalpels. By contrast, the retractable scalpels described in U.S. Pat. No. 5,201,748 to Newman et al., U.S. Pat. No. 5,258,001 to Corman, and U.S. Pat. No. 5,211,652 to Derbyshire, must be completely disassembled for the blade to be replaced, a non-standard time-consuming procedure that detracts from the nurses' ability to perform other tasks.
Other previously known safety scalpels, like those described in U.S. Pat. No. 5,344,424 to Roberts et al. and U.S. Pat. No. 5,330,493 to Haining do not even contemplate blade replacement, thus requiring the surgeon to have available and use several scalpels during the course of a single operation, at considerably higher cost than that of replacement blades alone.
U.S. Pat. No. 5,342,379 to Volinsky describes a safety scalpel wherein the scalpel blade is loaded in a disposable cartridge. Apart from the inability to replace the blade, the peculiar shape of the cartridge needed to accommodate the retraction mechanism of that patent provides the surgeon with little tactile ability to determine the proper orientation of the scalpel. Consequently, the surgeon must actually divert his or her eyes from the surgical field to confirm that the scalpel is being held with an appropriate orientation.
Yet another drawback of many previously known safety scalpel designs, including those described in the Newman et al., Roberts et al., Corman and Derbyshire patents, is the unnatural location of the knobs or latches used to actuate the retractable feature of these scalpels. In particular, the side-mounted locations of the actuators in these scalpels may require an unnatural or awkward motion of the thumb to extend the scalpel blade and also may require departure from conventional scalpel gripping points, for example, as taught in R. M. Kirk, BASIC SURGERY TECHNIQUES, Churchill Livingstone Publishers (3rd. ed. 1989), at pp. 5-6 and 9-11, and R. M. Zollinger and R. M. Zollinger, Jr., ATLAS OF SURGICAL OPERATIONS, MacMillan Publishing Co., (4th ed. 1975), at p. 22, which are incorporated herein by reference. Thus, previously known retractable scalpels require considerable effort by the surgeon to master effective use.
The above-noted ergonomic considerations also apply to scalpel blades having retractable sheaths, as described, for example, in U.S. Pat. No. 5,275,606 to Abidin et al and U.S. Pat. No. 5,292,329 to Werner. When retracted, the sheaths described in those patents cover the distal portion of the handle, thus requiring the surgeon to hold the scalpel by gripping the sheath. This mode of gripping the scalpel is expected to interfere with the surgeons' sense of touch, and it is therefore expected that the retractable sheaths described in those patents will receive only limited acceptance in the surgical community.
Yet another disadvantage of previously known safety scalpels is the use of multiple internal components, including buttons, springs, etc., for example, as shown in the above-mentioned Werner, Haugen and Newman et al. patents. For disposable devices, such complicated designs may lead to unreliability, and high manufacture and assembly costs, which are ultimately passed on to the consumer. For reusable devices, complicated designs may increase dramatically the effort required to disassemble the devices to ensure adequate cleaning and sterilization.
In view of the foregoing, it would be desirable to provide a scalpel handle having the physical and ergonomic characteristics of a standard non-retractable scalpel handle, but which provides a retractable blade support member. In particular, it would be desirable to provide a scalpel handle having the approximate external physical dimensions, weight and balance of commonly used previously known scalpel handles, e.g., such as the well-known Bard-Parker.RTM. scalpel handles, marketed by Becton-Dickinson Company, AcuteCare Division, Franklin Lakes, N.J., Aesculap, Inc., South San Francisco, Calif., as B-P.RTM. Surgical Handle Nos. 3 and 4, Part Nos. BB 73, BB 75 C, BB 84, BB 84 C, BB 88 and BB 89, and Pilling Co., Fort Washington, Pa., as Part Nos. 35-2950 through 35-2954, all of which are incorporated herein by reference. The Bard-Parker.RTM. scalpel handle has been the most commonly used medical scalpel for almost 100 years, as depicted by, for example, the cover of American College of Surgeons Bulletin, Jan. 1995, Vol. 80, No. 1, also incorporated herein by reference.
It further would be desirable to provide a scalpel handle having a retractable blade support member that accommodates a standard scalpel blade mounting post, and methods of use of such a scalpel, so that the blade may be replaced during use in essentially the same manner as conventional with scalpel handles.
It also would be desirable to provide a scalpel handle having a retractable blade support that includes an actuating tab that is positioned to permit the surgeon to extend and retract the scalpel blade, while holding the scalpel in a manner nearly identical to that currently employed when using standard non-retractable scalpels.
It also would be desirable to provide a scalpel handle having a retractable blade support that employs few working components and that is repeatedly sterilizable, or which includes a sterilizable main component and a disposable subcomponent.